ATE290216T1 - COAGULATION CONTROL FOR PT AND APTT TESTS - Google Patents

COAGULATION CONTROL FOR PT AND APTT TESTS

Info

Publication number
ATE290216T1
ATE290216T1 AT99928825T AT99928825T ATE290216T1 AT E290216 T1 ATE290216 T1 AT E290216T1 AT 99928825 T AT99928825 T AT 99928825T AT 99928825 T AT99928825 T AT 99928825T AT E290216 T1 ATE290216 T1 AT E290216T1
Authority
AT
Austria
Prior art keywords
plasma
heparin
anticoagulant
coagulation control
factor
Prior art date
Application number
AT99928825T
Other languages
German (de)
Inventor
Pamela L Hawkins
Original Assignee
Trinity Biotech Mfg Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Trinity Biotech Mfg Ltd filed Critical Trinity Biotech Mfg Ltd
Application granted granted Critical
Publication of ATE290216T1 publication Critical patent/ATE290216T1/en

Links

Classifications

    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/86Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood coagulating time or factors, or their receptors
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/96Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood or serum control standard
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2400/00Assays, e.g. immunoassays or enzyme assays, involving carbohydrates
    • G01N2400/10Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • G01N2400/38Heteroglycans, i.e. polysaccharides having more than one sugar residue in the main chain in either alternating or less regular sequence, e.g. gluco- or galactomannans, Konjac gum, Locust bean gum or Guar gum
    • G01N2400/40Glycosaminoglycans, i.e. GAG or mucopolysaccharides, e.g. chondroitin sulfate, dermatan sulfate, hyaluronic acid, heparin, heparan sulfate, and related sulfated polysaccharides
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2496/00Reference solutions for assays of biological material
    • G01N2496/05Reference solutions for assays of biological material containing blood cells or plasma

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Hematology (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Urology & Nephrology (AREA)
  • Food Science & Technology (AREA)
  • Biochemistry (AREA)
  • Cell Biology (AREA)
  • Biotechnology (AREA)
  • Medicinal Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Microbiology (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Saccharide Compounds (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)

Abstract

Coagulation control compositions suitable for use in connection with PT and/or APTT assays are disclosed along with their methods of preparation and methods of use. Preferred coagulation controls comprise plasma and an anticoagulant having activity for enhancing the activity of antithrombin III (ATIII) or of heparin co-factor II (HCII) against thrombin or against a clotting factor selected from the group consisting of factors IXa, Xa and XIa. The anticoagulant is preferably a glycosaminoglycan such as heparin, a heparin derivative or a heparin analog. The anticoagulant is preferably combined with (1) an abnormal plasma (e.g. activated plasma or factor-deficient plasma) and/or (2) a primate plasma (e.g. human plasma), and a non-primate mammalian plasma (e.g. bovine plasma). In the latter case, the non-primate mammalian plasma is preferably present in the coagulation control composition in an amount of not more than about 12% by volume, relative to total volume.
AT99928825T 1998-07-01 1999-06-21 COAGULATION CONTROL FOR PT AND APTT TESTS ATE290216T1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US09/108,732 US6194394B1 (en) 1998-07-01 1998-07-01 Coagulation controls for prothrombin time (PT) and activated partial thromboplastin time (APTT) assays
PCT/US1999/013974 WO2000002054A1 (en) 1998-07-01 1999-06-21 Coagulation controls for pt and aptt assays

Publications (1)

Publication Number Publication Date
ATE290216T1 true ATE290216T1 (en) 2005-03-15

Family

ID=22323751

Family Applications (1)

Application Number Title Priority Date Filing Date
AT99928825T ATE290216T1 (en) 1998-07-01 1999-06-21 COAGULATION CONTROL FOR PT AND APTT TESTS

Country Status (9)

Country Link
US (2) US6194394B1 (en)
EP (1) EP1092157B1 (en)
JP (1) JP2002519703A (en)
AT (1) ATE290216T1 (en)
AU (1) AU742965B2 (en)
CA (1) CA2334582C (en)
DE (1) DE69923974T2 (en)
ES (1) ES2237114T3 (en)
WO (1) WO2000002054A1 (en)

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AU744025B2 (en) * 1997-12-09 2002-02-14 Sigma-Aldrich Co. Plasma reference
US6541262B1 (en) 2000-04-28 2003-04-01 Medtronic, Inc. Method and device for testing a sample of fresh whole blood
US6682933B2 (en) 2002-03-14 2004-01-27 Lifescan, Inc. Test strip qualification system
US6673617B2 (en) 2002-03-14 2004-01-06 Lifescan, Inc. Test strip qualification system
US7358337B2 (en) * 2002-08-16 2008-04-15 International Technidyne Corporation Assay for low molecular weight heparin
US7247488B2 (en) * 2003-05-06 2007-07-24 Medtronic, Inc. Method and kit for testing a multi-channel blood assay cartridge
JP4787756B2 (en) * 2003-05-16 2011-10-05 ナショナル バイオロジカル スタンダーズ ボード Activation mixture
CA2566411A1 (en) * 2004-05-11 2005-11-24 Heptest Laboratories, Inc. Compositions, kit and one-step method for monitoring compounds having anti-factor xa and/or anti factor iia activities
US7148067B2 (en) * 2004-08-31 2006-12-12 The Board Of Trustees Of The University Of Illinois Thromboplastin reagents
WO2006088741A2 (en) * 2005-02-16 2006-08-24 The Board Of Trustees Of The University Of Illinois Procoagulants based on metal-chelating lipids
WO2006096345A2 (en) * 2005-03-04 2006-09-14 The Board Of Trustees Of The University Of Illinois Coagulation and fibrinolytic cascades modulator
DE102005028018A1 (en) * 2005-06-16 2006-12-21 Dade Behring Marburg Gmbh Method for the standardization of coagulation tests
FR2922024B1 (en) 2007-10-04 2011-03-25 Stago Diagnostica METHOD FOR ADJUSTING THE CALIBRATION OF DIAGNOSTIC TESTS
WO2009046194A2 (en) * 2007-10-05 2009-04-09 The Board Of Trustees Of The University Of Illinois Fibrin sealant
US20100297257A1 (en) * 2007-11-09 2010-11-25 National Institutes Of Health (Nih), U.S. Dept. Of Health And Human Services (Dhhs) Anticoagulant antagonist and hemophillia procoagulant
FR2933496B1 (en) * 2008-07-02 2012-10-05 Lfb Biotechnologies METHOD OF MEASURING ACTIVE FACTOR VII RATE IN A SAMPLE
IS2809B (en) 2011-03-08 2012-10-15 Haskoli Islands Method for monitoring anticoagulant therapy
US9354144B2 (en) 2011-09-20 2016-05-31 Bio-Rad Laboratories, Inc. Customized quality controls for analytical assays
EP2834635A4 (en) * 2012-04-03 2015-09-02 Smiths Medical Asd Inc Heparin-bulking agent compositions and methods thereof
CN103376329A (en) * 2012-04-19 2013-10-30 蓬莱诺康药业有限公司 Characterization method of stypticity of hemocoagulase atrox for injection and effective components thereof
WO2014205426A1 (en) * 2013-06-21 2014-12-24 Imigene, Inc. Blood analysis
AU2014384759B2 (en) * 2014-02-28 2021-07-22 Nitto Denko Corporation Urinalysis device and dry reagent for quantitative urinalysis
ES2475492B1 (en) * 2014-03-13 2015-01-15 Grifols Worldwide Operations Limited Composition for use as an abnormal coagulation control plasma in in vitro assays
JP2018524067A (en) 2015-06-11 2018-08-30 アットウィル メディカル ソルーションズ インコーポレイテッド Medical devices, systems and methods utilizing antithrombin-heparin compositions
CA3078625C (en) 2017-10-09 2023-01-17 Terumo Bct Biotechnologies, Llc Lyophilization container and method of using same
WO2020185916A1 (en) 2019-03-14 2020-09-17 Terumo Bct Biotechnologies, Llc Lyophilization container fill fixture, system and method of use
WO2022212162A1 (en) * 2021-03-31 2022-10-06 Haemonetics Corporation Hemostasis measurement device quality control formulations
CN117741166B (en) * 2024-02-19 2024-04-26 北京水木济衡生物技术有限公司 Multi-project composite coagulation quality control product and preparation method thereof

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US3947378A (en) 1974-12-23 1976-03-30 Warner-Lambert Company Adsorbed plasma
DE2461969A1 (en) 1974-12-31 1976-07-08 Behringwerke Ag STABLE BLOOD PLASMA, THE PROCESS FOR PRODUCING IT AND ITS USE AS A COMPARATIVE PLASMA IN COOLAGE EXAMINATIONS
US4007008A (en) 1975-07-30 1977-02-08 Becker Milton J Preparation of reference serum from animal blood
US4116635A (en) 1977-03-14 1978-09-26 Jaeger Mark A General purpose in vitro anticoagulant
US4127502A (en) 1977-06-10 1978-11-28 Eastman Kodak Company Stabilizers for reconstituted, lyophilized samples
DE2903701C2 (en) 1979-01-31 1980-10-16 Boehringer Mannheim Gmbh, 6800 Mannheim Control reagent for the determination of the heparin activity
US4543335A (en) * 1982-12-20 1985-09-24 Miles Laboratories, Inc. Device and method for the quantitative determination of heparin in mammalian blood plasma
US4948724A (en) * 1985-09-05 1990-08-14 Yin E Thye Composition, kit and method for assaying heparin and a method for making the composition
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Also Published As

Publication number Publication date
EP1092157B1 (en) 2005-03-02
CA2334582A1 (en) 2000-01-13
DE69923974T2 (en) 2005-07-21
AU742965B2 (en) 2002-01-17
CA2334582C (en) 2002-12-10
US20010004641A1 (en) 2001-06-21
ES2237114T3 (en) 2005-07-16
US6528273B2 (en) 2003-03-04
EP1092157A1 (en) 2001-04-18
JP2002519703A (en) 2002-07-02
WO2000002054A1 (en) 2000-01-13
DE69923974D1 (en) 2005-04-07
US6194394B1 (en) 2001-02-27
AU4580799A (en) 2000-01-24

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